Beschreibung
Clinical Operations Lead (Legacy BOPM) - Biomarker / Pharma / vendor / GCP / clinical / englishRole:
For our pharma client in Basel we are looking for a Clinical Operations Lead (Legacy BOPM) (m/w/d).
Background:
At Roche/Genentech, we have a bold Pharma Vision to achieve 3-5 times more patient benefit at 50% less cost to society. With this vision top of mind, Pharma Product Development (PD) Global Clinical Operations' (PDG) mission is to become an industry leader and disruptor in re[1]inventing how we organize ourselves and work. We seek to create new ways of working, always with the patient at the center of everything we do. Our shared purpose is to innovate clinical trial delivery to transform Roche's patient, caregiver, and site experience to bring better trials to more patients.
The perfect candidate:
The ideal candidate is someone with a scientific education, around 3 year of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to came in and quickly support. This person should have good experience with vendor and project management working in a global matrix environment. Experience with biomarker in a pharma and clinical setting would be appreciated. On a soft skill note, the perfect candidate is able to be independent, good communications skills & team player. Someone able to navigate a large matrix, global environment.
Areas of responsibility:
YOUR INITIAL FOCUS:
As a Clinical Operations Lead, your initial responsibilities will include:
- Provide BIOMARKER OPERATIONAL EXCELLENCE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for clinical studies.
- Collaborate with cross-functional STUDY and BIOMARKER TEAMS to execute biomarker operational strategies.
- Lead identification, selection and oversight of BIOMARKER VENDORS, ensuring quality delivery and performance.
- Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring study adherence to ICH/GCP and SOPs.
- LEAD AND INFLUENCE by establishing yourself as a leader within the team, inspiring others to perform at their best and learn from biomarker operations best practices. You will be shaping our capabilities and evolving your role over time.
DESIRABLE EXPERIENCES:
Background in life sciences. Laboratory experience in a clinical / biological / diagnostic setting. Project management. Experience in a pharmaceutical/biotechnology R&D environment.
Must haves:
- Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered)
- Minimum 3 years of experience in a clinical research setting, including at least 1 year working in pharma clinical operations
- Strong experience with vendor and project management
- Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
- Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological sample
- Experience working in a global and matrix environment
- Excellent collaboration, communication and presentation skills
Reference no: 921634
Role: Clinical Operations Lead (Legacy BOPM)
Industry: Pharmaceutical industry
Workload: 100%
Location: Basel, Switzerland
Start date: 01.07.2022
Duration: 12 months contract, with possible extension
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.